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Alleset

GRI Medical & Electronic Technology Co., Ltd. · Model SGB4280-COVER · UDI-DI 16931918155050

FMW
10
510(k) clearances
120
Adverse events (6 deaths)
3
Recalls
214
Facilities

Description

Safety Guard Mattress Cover for Fall protection for 42” Bariatric__80inX42inX8in_Bulk_N/S_12EA/CS

Recalls

DateFirmReason
2014-08-11Primus Medical LLCThe firm found that the top cover of the mattresses were delaminating.
2007-10-11Invacare CorporationIn October 2007 Invacare Corporation, Florida recalled CareGuard Mattresses, Models CG10180 and CG10180A, associated with IVC Bed Series Full Electric Beds, Semi-Electric Beds and
2007-08-29Invacare CorporationIn September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.